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Kapidex (Dexlansoprazole) - Indications and Dosage

 
 



INDICATIONS AND USAGE

1.1 Healing of Erosive Esophagitis

KAPIDEX is indicated for healing of all grades of erosive esophagitis (EE) for up to 8 weeks.

1.2 Maintenance of Healed Erosive Esophagitis

KAPIDEX is indicated to maintain healing of EE for up to 6 months.

1.3 Symptomatic Non-Erosive Gastroesophageal Reflux Disease

KAPIDEX is indicated for the treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks.

DOSAGE AND ADMINISTRATION

Table 1: KAPIDEX Dosing Recommendations

Indication Recommended Dose Frequency
Healing of EE 60 mg
Once daily for up to 8 weeks
Maintenance of Healed EE 30 mg
Once daily *
Symptomatic Non-Erosive GERD 30 mg
Once daily for 4 weeks

*     Controlled studies did not extend beyond 6 months.


2.2 Special Populations

No adjustment for KAPIDEX is necessary for patients with mild hepatic impairment (Child-Pugh Class A). Consider a maximum daily dose of 30 mg for patients with moderate hepatic impairment (Child-Pugh Class B). No studies have been conducted in patients with severe hepatic impairment (Child-Pugh Class C) [see Use in Specific Populations and Clinical Pharmacology].

No dosage adjustment is necessary for elderly patients or for patients with renal impairment [see Clinical Pharmacology ].

  • Alternatively, KAPIDEX capsules can be opened and administered as follows: – Open capsule; – Sprinkle intact granules on one tablespoon of applesauce; – Swallow immediately.
  • DOSAGE FORMS AND STRENGTHS

    • 30 mg capsules are opaque, blue and gray with TAP and "30" imprinted on the capsule.
    • 60 mg capsules are opaque, blue with TAP and "60" imprinted on the capsule.

    HOW SUPPLIED/STORAGE AND HANDLING

    KAPIDEX delayed release capsules, 30 mg, are opaque, blue and gray with TAP and "30" imprinted on the capsule and supplied as:

    NDC Number
    Size
    54868-5998-0
    Bottle of 30
    54868-5998-1 Bottle of 90                     

    Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature]

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